Hearing prosthesis electrode array with resiliently flexible tip member

ABSTRACT

A tip member for inserting into the cochlea, a device comprising: an elongate member including at least one electrode mounted thereon; and a tip member extending distally from a distal end of the elongate member, the tip member comprising a tapered portion tapering distally and a blunt end portion at a distal end of the tapered portion, wherein the tip member is resiliently flexible, and a method for making such a device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/825,358, filed Apr. 16, 2004, which claims priority from AustralianProvisional Patent Application No. 2003901868, entitled “Electrode Arraywith Bendable Tip” filed Apr. 17, 2003, each of which are herebyincorporated by reference herein.

BACKGROUND

1. Field of the Invention

The present invention relates generally to hearing prostheses, and moreparticularly, to a hearing prosthesis electrode array with a resilientlyflexible tip member.

2. Related Art

Electrode arrays, such as cochlear implant electrode arrays, generallyconsist of a plurality of electrode elements which are adapted to applyelectrical stimulation to surrounding tissue to stimulate thesurrounding nerves. In cochlear implant applications, the electrodearray is implanted within the cochlea of a recipient and appliesstimulation to the auditory nerves via a series of electrode elements,in accordance with a set stimulation pattern, controlled by an implantedstimulator unit.

The implanted stimulator unit typically applies the stimulation in amanner which is representative of a detected acoustic signal, such thatthe stimulation pattern applied by the electrode array stimulates theauditory nerves and elicits a sensation that closely resembles thenatural sensation of the detected acoustic signal.

In this regard, it is important that when implanting electrode arrays insensitive regions of the body, such as the cochlea, that the electrodearray be flexible enough to reduce damage to the sensitive structures ofthe surrounding tissue, and yet be rigid enough to ensure that thegeneral shape and form of the electrode array is maintained during theinsertion procedure such that the electrode array can perform asintended.

In electrode arrays of the type used for implantation in the cochlea, ithas been found that the tip of the array plays an important role duringthe insertion procedure. In this regard, there have been attempts todesign the tip of the electrode array in a manner that reduces thepossibility of the tip of the electrode array from puncturing orabrading the sensitive tissues of the cochlea and causing damage to thenerve structures which the implant is attempting to stimulate.

One such early attempt is described in Australian Patent No. 582264 toClark et al. This patent discloses the provision of tip or distal end ofthe electrode array being provided with at least one discontinuity thatincreases the flexibility of the tip. The tip is generally an extensionof the existing electrode array and is made from the same material, butis extending beyond the most distal electrode element.

One problem with such a design is that the tips were typicallyrelatively too flexible such that during the insertion process the tipwould catch on the wall of the cochlea and cause the array to bend backon itself, thereby potentially causing more damage to the cochlea thanwould ordinarily be the case should the flexible tip not be provided.Such a situation can also result in an implant being incorrectlypositioned from the auditory nerve potentially reducing theeffectiveness of the array in capturing and stimulating the appropriatenerves. Further, such a situation where the array folds upon itself cancause unwanted interaction or shorting between electrode elements thatmay be touching, thereby reducing the number of electrodes that may beoperational for stimulation.

Other designs have also considered providing an extended flexible tip ofa lead or electrode array to aid in insertion, such as that described inEP 0 919 254 to Bakels et al. However, as mentioned above, such tipshave all been designed with flexibility in mind rather than stability ofthe tip, hence all suffer from similar problems as identified above.

SUMMARY

In one aspect of the present invention, a hearing prosthesis isdisclosed. The hearing prosthesis comprises an elongate member,configured to be implanted into a duct of a recipient's cochlea, havinga preformed curved orientation, proximal and distal ends, electrodesdisposed thereon, and a longitudinally-extending lumen for receiving astiffening element; and a tip member, extending distally from the distalend of the elongate member, configured to have a substantially uniformbending stress distribution in an axial direction, and a lengthsufficiently short to avoid substantially damaging walls of the ductwhen the elongate member is in a fully implanted location in thecochlea, and sufficiently long to guide the elongate member through theduct to the fully implanted location as the elongate member adopts itspreformed curved orientation in response to withdrawal of the stiffeningelement from the lumen.

In another aspect of the present invention, a hearing prosthesis isdisclosed. The hearing prosthesis comprises an elongate member,configured to be implanted into a duct of a recipient's cochlea, havinga preformed curved orientation, proximal and distal ends, electrodesdisposed thereon, and a longitudinally-extending lumen for receiving astiffening element; and a tip member, extending distally from the distalend of the elongate member, having a substantially uniform bendingstress distribution and a length sufficiently long to prevent the tipmember from folding over as the elongate member adopts the preformedcurved orientation in response to withdrawal of the stiffening elementfrom the lumen.

In a further aspect of the present invention, a hearing prosthesis isdisclosed. The hearing prosthesis comprises an elongate member,configured to be implanted into a duct of a recipient's cochlea, havinga preformed curved orientation, proximal and distal ends, electrodesdisposed thereon, and a longitudinally-extending lumen for receiving astiffening element; and a tip member, extending distally from the distalend of the elongate member, having a substantially uniform bendingstress distribution and a length sufficiently long to prevent the tipmember from catching on the duct wall as the elongate member adopts thepreformed curved orientation in response to withdrawal of the stiffeningelement from the lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments off the invention will be described in conjunction with theaccompanying drawings, in which:

FIG. 1 is a force diagram of a prior art tip member used in electrodearrays;

FIG. 2 is a force diagram of another prior art tip member used inelectrode arrays;

FIG. 3A is a side view of a tip member in accordance with an embodimentof the present invention;

FIG. 3B is cross-sectional view of the tip member of FIG. 3A, takenalong line B-B.

FIG. 4A is a cross-sectional view of an electrode array in accordancewith one embodiment of the present invention in which tip member ofFIGS. 3A and 3B are mounted on an elongate member with only a portion ofthe elongate member being shown for simplicity;

FIG. 4B is an end-on view of the electrode array of FIG. 4A;

FIG. 5 is a simplified side elevational view of the electrode array ofFIGS. 4A and 4B of the present invention depicted in an intermediateorientation;

FIG. 6 is a simplified part sectional, part side elevational view of theelectrode array of FIGS. 4A and 4B depicted in its pre-formedorientation following insertion in the cochlea;

FIG. 7 is a simplified side elevation view of an electrode array inaccordance with another embodiment of the present invention depicted inan intermediate orientation; and

FIG. 8 is a cross-sectional view of an electrode array in accordancewith one embodiment of the present invention in which tip member ofFIGS. 3A and 3B are mounted on an elongate member with only a portion ofthe elongate member being shown for simplicity.

DETAILED DESCRIPTION

In one embodiment, the present invention provides an implantable tissuestimulating device, such as an electrode array, comprising: an elongateelectrode carrier member (elongate member) having a body having a firstend, and a resiliently flexible tip member extending distally from adistal end of the body. As used herein, a “distal” portion of an elementis the leading portion of the element when it is inserted into thecochlea. The elongate member has at least one electrode mounted thereonto apply preselected tissue stimulation, such as stimulation of a nervein a cochlea. The tip member includes a tapered portion taperingdistally and a blunt end at a distal end of the tapered portion. In oneembodiment of the present invention, the tip member includes a barrelportion at a proximal end of the tip member and the tapered portionextends distally from a distal end of the barrel portion. In a preferredembodiment, the tip member has a length of about 1.2 mm. As used herein,a “proximal” end of an element is the end opposite the distal end of theelement. Additionally, as used herein, an element “tapering distally”refers to an element that is tapered such that the diameter of theelement is smaller at the distal end of the element than at the proximalend.

In one embodiment of the present invention, the tip member may be formedof the same material as the body of the elongate member. In anotherembodiment, the tip member may be formed of a different material to thatof the body of the elongate member.

The tip member may be formed separately to the body of the elongatemember and mounted thereto. For example, the tip member may be adheredusing an adhesive to the first end of the body of the elongate member.Alternatively, the tip member may be mounted on the tip member by othermeans such as by snapping the tip member over a mating distal endportion of the elongate member, screwing the tip member onto the end athreaded distal end of the elongate member, hot welding together the tipmember and the elongate member, etc. In another embodiment, the tipmember may be integrally formed with the body of the elongate member.The tip member may be formed from a silicone material. In anotherembodiment, the tip member may be formed of an elastomeric material,such as polyurethane. In general, the tip member is made of any materialthat allows the tip member to be resiliently flexible.

In some embodiments the barrel portion of the tip member may be part ofa separate tip member that is joined to an elongate member, such as theembodiment of the present invention illustrated in FIGS. 5. In otherembodiments, the tip member may be formed as part of an elongate member,such as the embodiment illustrated in FIG. 7. The elongate member mayalso have a taper, but the tapered portion of the tip member will taperat a faster rate than the overall taper of the elongate member. Examplesof tapered elongate members are illustrated in FIGS. 5 and 7.

In one embodiment of the present invention, the barrel portion of a tipmember may be substantially cylindrical in form, i.e., have a generallycylindrical shape, for a portion of its length. In another embodiment,the barrel portion may be substantially cylindrical in form. As usedherein, an element may be “substantially cylindrical” and still includevarious raised or etched surface patterns and/or textures and may varyin width throughout the length of the part as long as the object hasroughly the same diameter at the proximal and distal ends of the part.In other embodiments the barrel portion may be various shapes andinclude various types of contouring. The barrel portion also may havevarious types of cross-sections besides the circular cross-section of acylindrical barrel. For example, the barrel portion may be elliptical incross-section, rectangular with rounded corners in cross-section,triangular with rounded corners in cross-section, etc.

The barrel portion in some embodiments may be slightly tapered, but insuch embodiments the tapered portion tapers at a faster rate than thebarrel portion.

In one embodiment of the present invention, the barrel portion is aboutor exactly 0.4 mm in length from the proximal end of the barrel portionto the distal end of the barrel portion where the tapered portionbegins. In one preferred embodiment where the barrel portion iscylindrical, the diameter of the barrel portion may be exactly or about0.45 mm.

In one embodiment for use with a tip member having a barrel portion witha 0.45 mm diameter the elongate member on which the tip member ismounted is slightly tapered and has a maximum diameter at its proximalend of about 0.80 mm and a minimum width or diameter at its distal endof about 0.5 mm. When the diameter of the distal end of the elongatemember is larger than the diameter of the barrel portion or a differentcross-sectional shape, such as illustrated in the embodiment of FIGS. 4Aand 4B, various means may be used to ensure a smooth transition betweenthe distal end of the elongate member and the barrel portion. Forexample, when a silicone adhesive is used to adhere the tip member tothe elongate member, some of the silicone adhesive may be used on thesurface of the barrel portion to form a tapered region filling the gapbetween the edges of the elongate member and the edges of the barrelportion as shown in FIG. 4A.

The barrel portion preferably includes a lumen therein that extends forsome or all of the length of the barrel portion. An example of such alumen is shown in the embodiment of the present invention illustrated inFIG. 3B. In one preferred embodiment, the lumen may be about 0.3 mm andhave a diameter of about 0.125 mm. The lumen may be adapted to receivethe distal end of a stiffening element, such as a stylet of the typetypically used with cochlear implants. An example of a distal end of astiffening element being received by a lumen is shown in the embodimentof the invention illustrated in FIG. 4A. The barrel portion preferablyhas a lumen therein that extends for some or all of its length. In oneembodiment of the present invention, the lumen may be about 0.3 mm.

In one embodiment of the present invention, the tapered portion may besubstantially frusto-conical in shape. In another embodiment, thetapered portion is frusto-conical in shape. In other embodiments, thetapered portion may be various tapered shapes that are continuouslytapered or non-continuously tapered. A part of a device may besubstantially frusto-conical and still include various raised or etchedsurface patterns and/or textures and may taper non-continuously as theobject has a proximal or distal end that is narrower than the oppositeend of the part.

For the purposes of the present invention, a part that tapers at a setrate throughout the length of the part has a “continuous taper”. Forexample, a tapered portion of a tip member that is frusto-conical has acontinuous taper in which the diameter of the tapered portion decreasesat a fixed rate from the proximal end of the tapered portion to thedistal end of the tapered portion. An example of a tapered portion of atip member of the present invention having a continuous taper isillustrated in FIG. 5. Also, for the purposes of the present invention,a part that does not taper at a set rate throughout the length of thepart the term has a “non-continuous taper”. For example, a part that issubstantially frusto-conical may have regions where the width of thepart remains constant without tapering, but which, viewed as a whole,tapers from one end to the other end of the part in an axial direction.

In one preferred embodiment, the tapered portion of the tip member maybe frusto-conical and has a length of about 0.76 mm and the diameter oftapered portion decreases from about 0.45 mm to exactly or about 0.2 mm.In one embodiment, the angle between notional diametrically opposedsides of a tapered portion that is frusto-conical is about or exactlyabout 18.9°. For the purposes of the present invention, the term“notional diametrically opposed sides” refers to the two opposing anglededges formed by cutting a tapered portion of a tip member of the presentinvention in half along the tapered portion's axis. The angle betweentwo notional diametrically opposed sides is the angle formed byextending two lines from the opposed sides, one line from each side, ina distal direction until the lines meet. In another embodiment thefrusto-conical tapered portion may have a length of about 0.76 mm Overthis length, the diameter of the frusto-conical portion decreases from0.45 mm to 0.2 mm.

Although one type of tapered portion of the present invention isdescribed above, the tapered portion of the present invention may have ashape other than frusto-conical and taper portions that arefrusto-conical or substantially frusto-conical may have an angle betweennotional diametrically opposed sides that is greater or less than 18.9°.

In one embodiment of the present invention, the blunt end of the tipmember is round in shape. In another embodiment, the blunt end of thetip member is spherical for a portion of its length. In otherembodiments, the blunt end may have various blunt shapes such asellipsoidal, paraboloidal, etc. The blunt end of a tip member of thepresent invention may be convex.

In one preferred embodiment, the blunt end is part-spherical in shapeand has length of about 0.04 mm and a maximum diameter of about 0.2 mmwhere the blunt end meets the distal end of the tapered portion.

In one embodiment, the tip member is designed so that when the tipmember is subject to a bending force, the moment of that force may beevenly distributed along the tip member and the bending stresses on thetip member are constant throughout its length. This even distributionprovides a tip member that is resiliently flexible, i.e. that is notsubject to foldover when the tip member is subject to a bending force,such as may occur during insertion of the tip member into a recipient ofthe device. For example, a resiliently flexible tip member will notundergo fold-over or bend backwards during insertion into a cochlea whenexposed to usual insertion forces necessary to insert a tip member of anelectrode array into a cochlea.

A tip member for which bending stresses on the tip member are constantthroughout its length has a uniform bending stress distribution. A tipmember that has a uniform bending stress distribution may be envisionedas, for example, a constant-strength cantilever beam where bendingstresses throughout the beam are equal to those at the fixed end, thatis, the junction of the tip member with the elongate member on which thetip member is mounted. In addition, a tip member may have asubstantially uniform bending stress distribution in an axial direction,which is a direction along a line extending through an element betweenthe distal and proximal ends of the device in either direction. Also, asused herein, an “axis” of an element is line through the middle of theelement. The “long axis” of an element is the longest axis that may bedrawn through the element, which may be the axis extending between theproximal and distal ends of an element.

In one embodiment the tissue-stimulating device may be a prosthetichearing implant, such as the cochlear implants made by Cochlear Limited,with the elongate member comprising a carrier member for a plurality ofelectrodes. The tip member in this embodiment may be constructed toassist in the guiding of the elongate member into the cochlea,particularly into the scala tympani of the cochlea.

In another embodiment the elongate member may have a first configurationselected to allow the elongate member to be inserted into a recipient'scochlea and at least a second configuration wherein the elongate memberis adapted to apply the preselected tissue stimulation. In oneembodiment of the present invention, the elongated member in the firstconfiguration is straight or substantially straight. However, in otherembodiments, the elongated member in the first configuration may becurved.

In one embodiment of the present invention, the second configuration ofthe elongate member is curved. In another embodiment, the elongatemember adopts a spiral configuration when in the second configuration.The body of the elongate member may be preformed from a plastic orrubber material with memory that is preformed to the secondconfiguration.

The elongate member may be formed from a resiliently flexible material.In a further embodiment, the tip member is resiliently flexible. In oneembodiment of the present invention, the tip member may be formed of amaterial having substantially the same or the same flexibility as thematerial used to form the body of the elongate member that encapsulatesthe electrode element(s) and wires.

In one embodiment of the present invention, the tip member may be formedof the same material as the body of the elongate member. In anotherembodiment, the tip member may be formed of a different material to thatof the body of the elongate member. For example, the tip member may beformed of a material having a relatively lesser stiffness than a portionof the body of the elongate member. In another embodiment, the tipmember may be formed of a material that undergoes a change in stiffness,preferably a decrease in stiffness, on insertion into the body, such asthe cochlea.

The tip member may be made as a separate unit and then mounted on to adistal end of the elongate member. For example, the tip member may beadhered to the distal end of the body of the elongate member or bemolded thereto in a secondary molding step. In one embodiment of thepresent invention, the tip member may be formed of an elastomericmaterial, such as polyurethane. The tip member may also be formed from asilicone material. In general the tip member may be made from anymaterial such as plastic or rubber that allows the tip member to beresiliently flexible.

In one embodiment of the present invention, the body of the elongatemember may be formed from a suitable biocompatible material. In oneembodiment of the present invention, the material may be a silicone. Inanother embodiment, the body may be formed from a suitable elastomericmaterial, such as polyurethane or other biocompatible rubbers orplastics.

In another embodiment, the elongate member may have a receiving portioninto which a stiffening element may be inserted. The device may furtherinclude a removable stiffening element positionable within the receivingportion of the elongate member and having a configuration selected forbiasing the elongate member into the first configuration, describedabove. The stiffening element is preferably relatively stiffer than theelongate member.

In one embodiment, the receiving portion may comprise a lumen extendingat least into, and more preferably through, the body of the elongatemember. The lumen for the stylet may be cylindrical and also may have anopening formed therein proximal to the tip member. In the case of ametal stylet, the stylet may extend out of the opening allowing thestylet to be manipulated and removed from the lumen during or followinginsertion of the device.

In one embodiment the stiffening element is formed of a bioresorbablematerial which dissolves on exposure to a fluid. The stiffening elementmay dissolve on exposure to a saline solution or a body fluid of theimplantee, such as cochlear fluid. In another embodiment, thebioresorbable material of the stiffening element is selected from thegroup consisting of polyacrylic acid (PAA), polyvinyl alcohol (PVA),polylactic acid (PLA) and polyglycolic acid (PGA).

In one embodiment of the present invention, the stiffening element maycomprise a stiffening element formed from a non-bioresorbable material.In this embodiment, the stiffening element may comprise a metallicstylet extending through the receiving portion of the body of theelongate member. In one embodiment of the present invention, the wiremay be formed from a biocompatible metal or metallic alloy. In oneembodiment of the present invention, the stylet may be formed fromplatinum. Other suitable stiffening elements and stylets for use in thepresent invention are also described in U.S. Pat. No. 6,421,569, U.S.patent application Ser. No. 10/070,102 filed Jul. 8, 2002, and U.S.patent application Ser. No. 10/203,079 filed Oct. 17, 2001, the entiredisclosures and contents of which are hereby incorporated by referenceherein.

In one embodiment of the present invention, the stiffening element maybe formed from a shape memory or heat sensitive material. For example,the stiffening element may be formed from a bimetallic element (such asnickel/titanium) and shaped to take a straight or substantially straightconfiguration at room temperature but bends into another shape once itis exposed to body temperature.

The construction of the electrode array of the present invention may beadapted to minimize the likelihood of trauma to the cochlea caused byinsertion of the electrode array. The construction of the tip member isenvisaged by the present inventors to assist in guiding the electrodedown the lumen of the scala tympani of the cochlea. It is also envisagedthat the construction of the tip member will minimize the potential forthe tip member of the electrode to perforate the basilar membrane of thecochlea or damage other sensitive structures in the cochlea.

The tip member of the present invention is useful for those elongatemembers inserted in the cochlea using an Advance Off-Stylet™ (AOS™) modeof implantation. (ADVANCE OFF-STYLET and AOS are trademarks of CochlearLimited, Lane Cove, NSW, Australia.) In this mode, the elongate memberwhile mounted on a stylet is inserted through a cochleostomy until thetip member is positioned just short of the basal turn of the cochlea.Once the tip member has reached this position, the elongate member maybe advanced or moved off the stylet and further into the scala tympani.As the elongate member is advanced off the stylet, the elongate memberis also free to begin to adopt its preferential spiral curvature. Theconstruction of the tip member of the present invention preventsfoldover of the tip member as the tip member is moved off the stylet.The length of the tip member, however, is also sufficiently short toensure that the tip member does not damage the walls of the scalatympani once the elongate member has reached its desired final insertionposition in the cochlea.

FIGS. 1 and 2 represent force diagrams of typical tip members of knownprior art electrode array carriers. It is possible from a review ofthese two diagrams to identify the problems with such prior art tipmembers.

FIG. 1 illustrates a prosthetic hearing implant device 100 including atip member 102 that is essentially an extension of an electrode arraycarrier member 104. For simplicity, only a portion of electrode arraycarrier member 104 is illustrated in FIG. 1. Electrode 106 is the mostdistal electrode of electrode array carrier member 104. Tip member 102has a bulbous distal end 108 a relatively narrow diameter neck section112 which is designed to provide increased flexibility to tip member102. As is shown, during insertion, a force (represented by arrow 122)is applied to tip member 102 when electrode array carrier member 100comes into contact with the wall of the cochlea (not shown) duringinsertion. Due to the force represented by arrow 122, tip member 102will flex about neck section 112 causing distal end 108 to undergoexcessive deflection, indicated by ghost lines 124, greatly increasingthe possibility of tip member 102 folding over upon itself duringinsertion.

FIG. 2 illustrates a prosthetic hearing implant device 200 including atip member 202 having a constant cross-sectional diameter d2 along thelength of tip member 202. Similar to tip member 102 shown in FIG. 1, tipmember 202 is essentially an extension a carrier member 204 for theelectrode array (not shown) beyond the position of the most distalelectrode (not shown). As is shown, when a force represented by arrow222 is applied to a distal end 228 of tip member 202, tip member 202will flex about a location 230 where tip member 202 joins carrier member204.

The design of the implant device illustrated in FIG. 2 increasesflexibility due to the long arm of the impact force and as such there isan increased risk of such a tip member design causing array foldover andpotential damage to the sensitive structures of the cochlea.

FIGS. 3A and 3B represent one embodiment of a tip member 302 of thepresent invention. Tip member 302 includes a cylindrical barrel portion304, a frusto-conical tapered portion 306 at a distal end 308 of barrelportion 304 and a part-spherical blunt end 310 at distal end 312 oftapered portion 306. Blunt end 310 terminates at tip member distal end313. Within cylindrical barrel portion 304 is a lumen 314 for receivinga stiffening element (not shown). Cylindrical barrel portion 304 hasdiameter 318 that is constant. In contrast, tapered portion 306 has adiameter that continuously decreases along the length of tapered portion306, as illustrated by exemplary diameters 320 and 322. Tip member 302is attached to a carrier member (not shown in FIG. 3) at a proximal end330 of tip member 302. An angle 332 between notional diametricallyopposed sides 334 and 336 of tapered portion 306 is 18.9°. Lumen 314 hasa constant diameter 342.

In the embodiment depicted in FIGS. 3A and 3B, the tip member isconstructed separately from the carrier member carrying the electrodearray. This allows the tip member to more easily be constructed in amanner that ensures the parameters of the tip member are appropriatelycontrolled to ensure that the tip member fulfills its designed purpose.

The tip member depicted in FIGS. 3A and 3B, may be constructed of anymaterial that allows the tip member to be resiliently flexible.

The dimensions and shape of tip member shown in FIGS. 3A and 3B allowsfor smooth insertion of an electrode array to which the tip member isattached while preventing tip member foldover.

In one embodiment of the present invention, the barrel portion of thetip member shown in FIGS. 3A and 3B may be exactly or about 0.4 mm inlength and the diameter of the barrel portion may be exactly or about0.45 mm for all or at least some of its length.

In one embodiment, the lumen in the tip member of FIGS. 3A and 3B has adiameter of about 0.125 mm and a length of about 0.3 mm.

In one embodiment of the present invention, the tapered portion of thetip member of FIGS. 3A and 3B has a length of about 0.76 mm and overthis length the diameter of the tapered portion decreases from about0.45 mm to 0.2 mm.

In one embodiment of the present invention, the length of thepart-spherical blunt end has a length of about 0.04 mm and over thislength the diameter of blunt end decreases from about 0.2 mm to 0.0 mmat the very distal end of the blunt end.

FIGS. 4A and 4B illustrate an electrode array 400 in accordance with oneembodiment of the present invention. Electrode array 400 includes tipmember 302 mounted on an elongate member 402, only a portion of which isshown in FIG. 4A. Elongate member 402 includes a lumen 404 extendingtherethrough. Tip member 302 is held on elongate member 402 by means ofa liquid silicone rubber adhesive 406. Filler portions 408 of adhesive406 smooth the transition from elongate member 402 to tip member 302,because in this embodiment a distal end 410 of elongate member 402 has alarger diameter than tip member proximal end 330. For illustrationpurposes, the amount of adhesive 406 between elongate member distal end410 and tip member proximal end 330 is exaggerated in the depiction inFIG. 4A. A stylet 422 inserted into elongate member extends throughlumen 404 and into lumen 314 of tip member 302. Elongate member 402 isslightly tapered, but the taper of elongate member 402 is not as greatas the taper of tapered portion 306 of tip member 302. Elongate member402 includes electrodes 432 on one side of elongate member 402. Duringinsertion into a cochlea (not shown), tip member 302 may be subject toan impact/deflection force represented by arrow 442. As illustrated inFIG. 4B, elongate member 402 has a rounded corner square shapedcross-section having a minimum width 452.

As illustrated in FIG. 4A, the tip member provides a smooth transitionof flexibility from the relatively stiff portion of the carrier membercontaining the electrode elements and wires (not shown) to the moreflexible blunt end of the tip member.

Although the elongate member shown in FIG. 4B has a rounded cornersquare shaped cross-section, the elongate member of the presentinvention may have various cross-sectional shapes such as circular,elliptical, rectangular, etc. and the cross-sectional shape of theelongate member may vary over the length of the elongate member.

FIG. 5 illustrates electrode array 400 in a curved orientation. Uponinsertion of electrode array 400 into the scala tympani of the cochlea(not shown), the exposure of electrode array 400 to body temperature(about 37° C.) results in stylet 422 adopting a curved orientation. Asstylet 422 adopts a curved orientation, elongate member 402 is free toalso adopt the curved orientation as is depicted in FIG. 5.

As the elongate member 402 curls, the surgeon may continue to furtherinsert electrode array 400 into scala tympani 622 of a cochlea 624 asillustrated in FIG. 6. During the further insertion process, the surgeonmay commence withdrawal of stylet 422 from lumen 404 of elongate member402. Alternatively, the surgeon may withdraw stylet 422 followingcomplete insertion of electrode array 400 into its final position, thisdecision being dependent of the surgeon's preferences. Upon withdrawalof stylet 422, elongate member 402 is free to adopt its pre-formedspiral orientation, as depicted in FIG. 6, with electrodes 432 (notvisible in FIG. 6) facing the modiola (not visible in FIG. 6) withincochlea 624 so that electrodes 432 are positioned as close as possibleto the spiral ganglia thereof.

FIG. 7 illustrates an electrode array 702 of the present inventionincluding a tip member 704 that is integral with an elongate member 706.A stylet 708 is inserted through a lumen in elongate member 706 and intoa lumen in tip member 704. Electrode array 702 is essentially similar toelectrode array 400 in both structure and function, except that tipmember 704 is integral with elongate member 706 whereas in electrodearray 400 tip member 302 is mounted on elongate member 402. Asillustrated in FIG. 7, electrode array 702 is in a curved orientation,similar to the curved orientation of electrode array 400 in FIG. 5.

While an elongate member of the present invention, such as the elongatemembers of FIG. 5 and FIG. 7, may be manufactured with a preformedcurved orientation, the device is typically delivered to a surgeon withthe stylet in place. The stylet, while at room temperature, holds theelongate member in a straight orientation. A useful stylet for thepurposes of the present invention may be a Nitinol wire.

FIG. 8 illustrates an electrode array 800 in accordance with oneembodiment of the present invention. Electrode array 800 includes tipmember 302 mounted on an elongate member 802, only a portion of which isshown in FIG. 8. Elongate member 802 includes a lumen 804 extendingtherethrough. A distal end 810 of elongate member 802 has the same sizediameter and is the same shape as tip member proximal end 330, so thereis a smooth transition between elongate distal end 810 and tip memberproximal end 330. A stylet 822 inserted into elongate member extendsthrough lumen 804 and into lumen 314 of tip member 302. Elongate member802 is slightly tapered, but the taper of elongate member 802 is not asgreat as the taper of tapered portion 306 of tip member 302. Elongatemember 802 includes electrodes 832 on one side of elongate member 802.During insertion into a cochlea (not shown), tip member 302 may besubject to an impact/deflection force represented by arrow 842.

In the electrode arrays of the present invention, such as the electrodearrays illustrated in FIGS. 5, 6 and 7, the stylet may have a preferreddirection of curl on exposure to body temperature within the cochlea. Inone embodiment, the electrode array may have an indicia means thatprovides an indication to a user, such as a surgeon, of the preferreddirection of curl of the electrode array on implantation. This may beimportant as the electrode array is preferably oriented in the cochleasuch that the direction of curl results in the electrode array beingable to be moved into the scala tympani. The indicia means may comprisea loop formed in the wire at or adjacent a distal end thereof. The loopas well as acting as an indicia means may act as a means of engagingwith and withdrawing the stylet from the lumens in the elongate memberand tip member during or following implantation. In one embodiment, theloop may be in the same plane as the preferred direction of curl of thestylet. The loop may extend away from the preferred direction of curl ofthe stylet.

In one embodiment of the present invention, it is possible to provide asheath of bioresorbable and lubricious material, similar to the sheathdescribed and shown in U.S. patent application Ser. No. 10/203,079, theentire disclosure and contents of which is hereby incorporated byreference herein. The bioresorbable material of stiffening sheath may bepolyacrylic acid (PAA) that is adapted to dissolve on exposure tocochlear fluids. Other suitable bioresorbable materials may be envisagedand such materials need not necessarily dissolve on exposure to fluids.For example, the sheath may be made of a material that softens uponexposure to fluids but does not get absorbed.

As mentioned above, in one embodiment of the present invention, the tipmember may be constructed separately from the elongate member ofelectrode array. In this regard, the tip member may be constructed outof a similar material to the body of the electrode array carrier such assilicone. To aid in fixing the tip member to the elongate member duringproduction, the tip member lumen may be used to fit over a productionstylet positioned within the lumen of the elongate member of theelectrode array during its manufacture. Such a production stylet may beplaced in a mold, along with the electrodes, and a suitable quantity ofsilicone is then poured into the mould around the stylet and electrodesto form the elongate member. In the present embodiment, the distal endof the production stylet would preferably extend a relatively shortdistance out of the distal end of the molded carrier member and act as asupport for the tip member lumen of the tip member when the tip memberis subsequently securely mounted on the distal end of the elongatemember. A suitable production stylet and a method of manufacturing theelongate member of the electrode array of the present invention isdescribed in more detail in U.S. Pat. No. 6,421,569, the entiredisclosure and contents of which is hereby incorporated by referenceherein.

Suitable elongate members for use with the tip member of the presentinvention and methods for inserting a device of the present inventioninto a cochlea are described in U.S. Pat. No. 6,421,569, U.S. patentapplication Ser. No. 10/070,102 filed Jul. 8, 2002, and U.S. patentapplication Ser. No. 10/203,279 filed Oct. 17, 2001, the entiredisclosures and contents of which are hereby incorporated by referenceherein.

The present invention provides a specifically designed tip of anelectrode array that is shaped and dimensioned in a manner to optimizethe flexibility of the array such that the tip will not undergofold-over during insertion when exposed to usual insertion forces. Thisinvention is a significant improvement over prior art attempts atproviding such a flexible tip as embodiments of the present inventionovercome the problem of the tip being too flexible at a critical sectionand becoming too flexible to enable smooth insertion of the array.

In one embodiment of the tip member of the present invention having ashape such as shown in FIGS. 3A and 3B, the design of the tip member maybe based upon establishing the dimensions of three main parameters:

-   -   D1 is the diameter of the proximal end of the tip member that is        connected to the elongate member;    -   D2 is the diameter of the distal end of the frusto-conical        tapered portion; and    -   L is the length of the tip member.

The diameter D1 of the tip member in this embodiment at its proximal endthat is connected to the end of the elongate member is preferablyexactly or about 0.45 mm. This diameter allows the tip member to beeasily fitted onto the end of a conventional electrode array, such asthe Contour electrode array manufactured by Cochlear Limited of LaneCove, New South Wales, Australia.

The diameter D2 of the distal end of the frusto-conical tapered portionof the tip member in this embodiment is preferably exactly or about 0.2mm. This diameter has been determined based upon studies andexperimental measurements of human cochlea and the sizes of the diameterof the outer wall of the cochlea as a dimension most likely to minimizethe chance of the tip member penetrating the outer wall.

The length L of the tip member in this embodiment is preferably exactlyor about 1.2 mm. Again, this dimension has been determined as beingsuitable for ensuring the tip fits within the appropriate region insidethe cochlea for a range of initial electrode array insertion depths. Ithas been found that such a length of the tip member minimizes thelikelihood of, and more preferably avoids, tip foldover for typicalforces associated with electrode array insertion.

Having determined the important parameters of the tip of the presentinvention, namely D1, D2 and L, the shape of the tip member in thisembodiment provides great flexibility whilst providing smooth mechanicalinteraction between the tip member and the cochlea thereby providing asmooth insertion procedure. The shape of the tip member in thisembodiment takes into consideration the mechanical design requirementsof the tip member. The shape and dimensions of the tip member of thisembodiment is based on the idea of treating the tip member as acantilever beam and determining the dimensions of a constant-strengthcantilever beam where bending stresses throughout the beam are equal tothose at the fixed end, that is, the junction of the tip member with theelongate member.

In this regard, the general stress formula for such a cantilever beam(assuming a rectangular cross-section) is:

σ=6FL/(bh ²)

where σ is the stress;

-   -   F is the deflection/impact force; and    -   L, b, h are the beam length, fixed end width, and height,        respectively.

Assuming that the tip member is attached to a substantially tubularelongate member, the preferred cross-section of the tip member iscircular, so that there is maximum alignment between the elongate memberand the tip member when the tip member is attached to the elongatemember during production. In this regard, for a circular beam theconstant stress formula may be written as:

σ=k(const.)×((F.x)/D ³)

where x is arm of force F (see FIG. 4A); and

-   -   D is the diameter for the circular beam.

Therefore, for a given impact/deflection force F (constant), in order toachieve uniform strength the following formula may be found:

X/D ³ =k′(const.)

Therefore the formula for D as a function of x is:

D=k″(const.)×cube root(x)

Given the abovementioned established parameters of the tip member,namely D1, D2 and L, the following equations may be determined:

0.2=k″(const)×cube root(x)

0.45=k″(const)×cube root (x=1.2)

As a result, in order to control the distribution of the force over thelength of the tip member, the shape of the tip member of this embodimentmay be approximated to the partially frusto-conical tapered shape asdepicted in FIG. 3A.

All documents, patents, journal articles and other materials cited inthe present application are hereby incorporated by reference herein.

Although the present invention has been fully described in conjunctionwith several embodiments thereof with reference to the accompanyingdrawings, it is to be understood that various changes and modificationsmay be apparent to those skilled in the art. Such changes andmodifications are to be understood as included within the scope of thepresent invention as defined by the appended claims, unless they departtherefrom.

1. A hearing prosthesis comprising: an elongate member, configured to be implanted into a duct of a recipient's cochlea, having a preformed curved orientation, proximal and distal ends, electrodes disposed thereon, and a longitudinally-extending lumen for receiving a stiffening element; and a tip member, extending distally from the distal end of the elongate member, configured to have a substantially uniform bending stress distribution in an axial direction, and a length sufficiently short to avoid substantially damaging walls of the duct when the elongate member is in a fully implanted location in the cochlea, and sufficiently long to guide the elongate member through the duct to the fully implanted location as the elongate member adopts its preformed curved orientation in response to withdrawal of the stiffening element from the lumen.
 2. The hearing prosthesis of claim 1, wherein the length of the tip member is about 1.2 mm.
 3. The hearing prosthesis of claim 1, wherein the tip member is resiliently flexible.
 4. The hearing prosthesis of claim 1, wherein the duct is the scala tympani of the cochlea.
 5. The hearing prosthesis of claim 1, wherein the electrodes are disposed on the elongate member such that the electrodes face the modiola of the cochlea when the elongate member is in the fully implanted location and has adopted its preformed curved orientation.
 6. The hearing prosthesis of claim 1, wherein the tip member comprises a lumen radially-disposed within the tip member.
 7. The hearing prosthesis of claim 1, wherein bending stresses through the tip member are substantially equal to bending stresses at the junction of the tip member and the elongate carrier member.
 8. A hearing prosthesis comprising: an elongate member, configured to be implanted into a duct of a recipient's cochlea, having a preformed curved orientation, proximal and distal ends, electrodes disposed thereon, and a longitudinally-extending lumen for receiving a stiffening element; and a tip member, extending distally from the distal end of the elongate member, having a substantially uniform bending stress distribution and a length sufficiently long to prevent the tip member from folding over as the elongate member adopts the preformed curved orientation in response to withdrawal of the stiffening element from the lumen.
 9. The hearing prosthesis of claim 8, wherein the length of the tip member is about 1.2 mm.
 10. The hearing prosthesis of claim 8, wherein the tip member is resiliently flexible.
 11. The hearing prosthesis of claim 8, wherein the duct is the scala tympani of the cochlea.
 12. The hearing prosthesis of claim 8, wherein the tip member comprises: a substantially cylindrical barrel portion at a proximal end of the tip member; a conical tapered portion at a distal end of the barrel portion, the conical tapered portion tapering distally; and a blunt end portion at a distal end of the tapered portion.
 13. The hearing prosthesis of claim 12, wherein the conical tapered portion tapers continuously.
 14. The hearing prosthesis of claim 12, wherein the angle between notional diametrically opposed sides of the conical tapered portion is about 18.9 degrees.
 15. The hearing prosthesis of claim 12, wherein the blunt end portion has one of an ellipsoidal shape and a spherical shape.
 16. A hearing prosthesis comprising: an elongate member, configured to be implanted into a duct of a recipient's cochlea, having a preformed curved orientation, proximal and distal ends, electrodes disposed thereon, and a longitudinally-extending lumen for receiving a stiffening element; and a tip member, extending distally from the distal end of the elongate member, having a substantially uniform bending stress distribution and a length sufficiently long to prevent the tip member from catching on the duct wall as the elongate member adopts the preformed curved orientation in response to withdrawal of the stiffening element from the lumen.
 17. The hearing prosthesis of claim 16, wherein the length of the tip member is about 1.2 mm.
 18. The hearing prosthesis of claim 16, wherein the tip member is resiliently flexible.
 19. The hearing prosthesis of claim 16, wherein the duct is the scala tympani of the cochlea.
 20. The hearing prosthesis of claim 16, wherein the tip member is formed from the same material as the elongate member.
 21. The hearing prosthesis of claim 16, wherein the elongate member is formed of a first material and the tip member is formed of a second material.
 22. The hearing prosthesis of claim 21, wherein the first material has substantially the same flexibility as the second material.
 23. The hearing prosthesis of claim 21, wherein the first material has a relatively greater stiffness than the second material.
 24. The hearing prosthesis of claim 21, wherein the second material is configured to undergo a decrease in stiffness upon implantation into the cochlea.
 25. The hearing prosthesis of claim 16, wherein the tip member is integral with the elongate member.
 26. The hearing prosthesis of claim 16, wherein the tip member is mounted on the distal end of the elongate carrier member.
 27. The hearing prosthesis of claim 16, wherein the tip member comprises at least one of a silicone material, an elastomeric material, plastic, and rubber. 